FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000
K Number: K052073
·
Decision Oct 26, 2005
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
329
Applicant Total
5
Review Days
86
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Basic Information
- Device Name
- FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000
- K Number
- K052073
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Schutz-Dental GmbH
- Date Received
- August 1, 2005
- Decision Date
- October 26, 2005
- Product Code
- EBI
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | FDA class 2 | Dental |
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Other Clearances by Schutz-Dental GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K133268 | TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS | Feb 12, 2015 | Substantially Equivalent |
| K071010 | TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS | Aug 24, 2007 | Substantially Equivalent |
| K052189 | REVENEER CERAMIC REPAIR SYSTEM | Oct 17, 2005 | Substantially Equivalent |
| K051050 | SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092 | Jun 29, 2005 | Substantially Equivalent |